Prescription drug · ANDA
Diclofenac Sodium NDC 80425-0235
Diclofenac sodium 30 mg/g · Gel · Topical · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0235-1 | 80425023501 | 1 TUBE in 1 CARTON (80425-0235-1) / 100 g in 1 TUBEMarketed from Jan 10, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Diclofenac Sodium
- Generic name (nonproprietary)
- diclofenac sodium
- Active ingredients
- Diclofenac sodium — 30 mg/g
- Dosage form
- Gel
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206298
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 80425-0235_2a9aec09-6308-2252-e063-6294a90a204aSPL ID 2a9aec09-6308-2252-e063-6294a90a204aSPL set ID f1892aae-7264-3b4c-e053-2995a90a8802RxCUI 855642UNII QTG126297Q
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N480425023501followed by a unit qualifier and the quantityPackage 80425-0235-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Indications and Usage Diclofenac Sodium Gel is indicated for the topical treatment of actinic keratoses (AK). Sun avoidance is indicated during therapy.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206298
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Diclofenac Sodium | Diclofenac sodium 30 mg/g | GelTopical | Direct_Rx | 72189-040 |
| Diclofenac sodium | Diclofenac sodium 30 mg/g | GelTopical | Proficient Rx LP | 71205-538 |
| Diclofenac sodium | Diclofenac sodium 30 mg/g | GelTopical | Sun Pharmaceutical Industries, Inc. | 51672-1363 |
| Diclofenac sodium | Diclofenac sodium 30 mg/g | GelTopical | Asclemed USA, Inc. | 76420-275 |
| Diclofenac sodium | Diclofenac sodium 30 mg/g | GelTopical | NuCare Pharmaceuticals,Inc. | 68071-3688 |
| Diclofenac sodium | Diclofenac sodium 30 mg/g | GelTopical | Preferred Pharmaceuticals Inc. | 68788-8236 |
| Diclofenac sodium | Diclofenac sodium 30 mg/g | GelTopical | Preferred Pharmaceuticals Inc. | 68788-4118 |